Table 3 Brazilian license situation, indications for neonates and off–label use in neonates in Brazil
From: Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study
MICROMEDEX | BNFC 2012–2013 | |||||||
|---|---|---|---|---|---|---|---|---|
n (%) | Indicated (%) | Not (%) | NI (%) | Indicated (%) | Not (%) | NI (%) | Most frequent drugs (neonates) | |
Licensed | 329 (19.1) | 78.7 | 21.3 | -- | 75.4 | 24.6 | -- | domperidone (59)a,c, vancomycin (55), pulmonary surfactant (49), phytomenadione (47), furosemide (29), epinephrine (26) |
Unlicensed | 38 (2.2) | 36.8 | 7.9 | 55.3 | 47.4 | -- | 52.6 | tricalciumphosphate (18)b,d, alprostadil (2), biotin (2), L-carnitine (2), riboflavin (2), thiamine (2) |
Off-label | 1358 (78.7) | 64.8 | 22.9 | 12.3 | 90.6 | 3.0 | 6.4 | |
Age | 869 (50.4) | 55.6 | 33.0 | 11.4 | 87.8 | 2.8 | 9.4 | heparin (97), fentanyl (92), multivitamins without minerals (91)b, aminophylline (87), ranitidine (53), metamizole (37)a,d, cefepime (31)a,d, omeprazole (29)a |
Dose/frequency | 345 (20.0) | 82.9 | 1.7 | 15.4 | 98.8 | 1.2 | -- | gentamicin (110), ampicillin (108), amikacin (36), vancomycin (15), midazolam (3), ampicillin/sulbactam (5) |
Age, pharmaceutical form | 23 (1.3) | 34.8 | 65.2 | -- | 95.7 | 4.3 | -- | spironolactone (7), methadone (6), captopril (3), propranolol (2), sildenafil (2) |
Age, route of administration | 29 (1.7) | 48.3 | -- | 51.7 | 51.7 | 48.3 | -- | multivitamins without minerals (15)b, mineral oil (14)b,c |
Route of administration | 61 (3.5) | 96.7 | 3.3 | -- | 96.7 | 3.3 | -- | phytomenadione (59), nystatin (2)a,c |
Age, form, route of administration | 14 (0.8) | 100.0 | -- | -- | 100.0 | -- | -- | aminophylline (14) |
Age, dose/frequency | 8 (0.5) | 100.0 | -- | -- | 100.0 | -- | -- | aminophylline (8) |
Indication, pharmaceutical form, route of administration | 6 (0.3) | 100.0 | -- | -- | 100.0 | -- | -- | epinephrine (6) |
Age, indication, pharmaceutical form | 1 (0.1) | 100.0 | -- | -- | 100.0 | -- | -- | acetylsalicylic acid (1)a |
Dose/frequency, pharmaceutical form | 2 (0.1) | 100.0 | -- | -- | 100.0 | -- | -- | furosemide (1), levothyroxine (1) |
Total | 1725 (100.0) | 66.8 | 22.3 | 10.9 | 86.8 | 7.1 | 6.1 | |